COPDNCT00962078

Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

A study testing continuous endurance training and interval training in people with COPD and Pre-Lung-Transplantation, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to study the effects of a complex pulmonary rehabilitation program on mobility measured by 6 minute walking distance (6MWD) and physical activity, measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL (SF36, EuroQul)), anxiety and depression (HADS)and… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: COPD, Pre-Lung-Transplantation, Hypercapnia
What is being tested?: continuous endurance training and interval training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteGermany
Study dates: Jul 2008to Oct 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

pre-LTx (listed for lung-transplantation or currently undergoing evaluation)
COPD Stadium IV GOLD
α-1-Antitrypsin-deficiency-Emphysema
respiratory Insufficiency
oxygen therapy (LTOT)

Who cannot join

serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation
clinical signs of manifest heart insufficiency
acute coronar syndrome
left heart insufficiency(EF < 40%)
missing Compliance

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinikum Berchtesgadener Land
Schönau am Königssee, 83471

Other trials in Germany

About this study

Official title: Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)

Conditions: COPD, Pre-Lung-Transplantation, Hypercapnia, Respiratory Insufficiency
Being tested: continuous endurance training, interval training
Keywords: COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Hypercapnia, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

continuous endurance trainingOther
at 60 percent of peak Watt
interval trainingOther
at 100 percent of peak Watt

Study groups in NCT00962078
Study group	Role	What they receive
interval training	Other	interval training in lung transplant candidates Receives: Other: interval training
Continuous Training	Other	continuous training in lung transplant candidates Receives: Other: continuous endurance training

What is being measured

The primary outcome is the main question the study is designed to answer.

Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Measured: value at day 21 minus value at day 1

Secondary outcomes (1)

Dyspnoea During Exercise Measured on the Borg Scale
The Borg scale is a numeric scale that ranges from 0 to 10 points to rate dyspnea.
The scale is like follows:
0 Nothing at all
1. Very slight
2. Slight
3. Moderate
4. Somewhat severe
5. Severe
7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal
Measured: mean values from day 1 to day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Oct 2010

First posted19 Aug 2009 (estimated)
Study startJul 2008
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00962078
Sponsor's protocol ID: PRÄ-LTX-08022
Other IDs: Ethikkommission, Landesärztekammer Bayern, Nr. 08022
Status last verified: Aug 2019
First submitted: 27 Jul 2009
Last updated: 23 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)
ClinicalTrials.gov ID: NCT00962078
Acronym / sponsor ID: PRÄ-LTX-08022
Conditions: COPD, Pre-Lung-Transplantation, Hypercapnia, Respiratory Insufficiency
Keywords: COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Schön Klinik Berchtesgadener LandUniversity, hospital or other
Study start: Jul 2008 (actual)
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 19 Aug 2009 (estimated)
Results: Posted 23 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
interval training	Other	Other: interval traininginterval training in lung transplant candidates
Continuous Training	Other	Other: continuous endurance trainingcontinuous training in lung transplant candidates

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

pre-LTx (listed for lung-transplantation or currently undergoing evaluation)
COPD Stadium IV GOLD
α-1-Antitrypsin-deficiency-Emphysema
respiratory Insufficiency
oxygen therapy (LTOT)

Key exclusion criteria (5 listed)

serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation
clinical signs of manifest heart insufficiency
acute coronar syndrome
left heart insufficiency(EF < 40%)
missing Compliance

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
continuous endurance trainingat 60 percent of peak Watt	Other	Continuous Training
interval trainingat 100 percent of peak Watt	Other	interval training

Primary outcome

Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Time frame: value at day 21 minus value at day 1

1 secondary outcome

Dyspnoea During Exercise Measured on the Borg Scale
Time frame: mean values from day 1 to day 21

Results and safety

Results posted to the registry on 23 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interval Training	35	30
Continuous Training	36	30

Primary outcome: Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)

Time frame: value at day 21 minus value at day 1. Mean (Standard Deviation). Unit: meter

Measure	Interval Training n = 30	Continuous Training n = 30
Value	35 (29)	36 (42)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interval Training	0 of 35 (0%)	0 of 35 (0%)	Not reported
Continuous Training	0 of 36 (0%)	0 of 36 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Klaus Kenn, Dr.med. study director

Klinikum Berchtesgadener Land, Schön-Kliniken

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing continuous endurance training and interval training in people with COPD and Pre-Lung-Transplantation, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD) (time frame: value at day 21 minus value at day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00962078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.